Cardiac Dimensions: eerste aanmeldingen voor onderzoek REDUCE FMR
Cardiac Dimensions heeft vandaag bekendgemaakt dat de eerste patiënten zich hebben aangemeld voor het klinische onderzoek REDUCE FMR. Het onderzoek is een prospectieve, dubbelblinde en gerandomiseerde proef in meerdere centra met Dardiac Dimensions’ minimaal invasief CARILLON Mitral Contour System.
REDUCE FMR, waaraan twintig toonaangevende ziekenhuizen in Europa en Australië meewerken, verdeelt 120 patiënten willekeurig over onderzoeksgroepen. Het onderzoek is opgezet om CARILLON te vestigen als gouden standaard voor de behandeling van functionele mitralisinsufficiëntie. Mensen met deze aandoening hebben een abnormaal grote mitralisklep, waardoor de bloedtoevoer naar het lichaam beperkt is. Alle patiënten die meewerken aan het onderzoek krijgen een optimale medicijnkuur tegen hartfalen en zijn willekeurig verdeel in twee groepen. Een groep krijgt naast medicijnen ook een behandeling met CARILLON. De andere groep krijgt een medicijnkuur, wat momenteel gezien wordt als de gouden standaard tegen mitralisinsufficiëntie.
Cardiac Dimensions Announces Initial Enrollments in REDUCE FMR Clinical Trial
Cardiac
Dimensions® today announced that the first patients have
been enrolled in the REDUCE FMR clinical trial. REDUCE FMR is a
prospective, double-blind, randomized multi-center trial, evaluating the
company’s minimally-invasive CARILLON®
Mitral Contour System®.
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The CARILLON® Mitral Contour System® (Photo:
Business Wire)
Involving up to 20 leading hospitals in Europe and Australia, REDUCE FMR
will randomize 120 patients and is designed to establish CARILLON as the
gold standard treatment for Functional Mitral Regurgitation (FMR) – a
condition in which blood flow to the body is reduced due to an
abnormally enlarged mitral valve. All patients enrolled in the study are
on an optimized heart failure medication regimen and are then randomized
into two groups: one additionally treated with the CARILLON device and
the second remaining on an optimized regimen of heart failure
medications, the present gold standard.
The study design contains some unique elements aimed at optimizing
recruitment and enrollment, including a 3:1 randomization ratio allowing
for more data to be collected with the CARILLON device and a cross-over
registry which allows control patients to receive CARILLON treatment at
the end of their 12-month follow up. A built-in exercise
echocardiographic sub-study will further evaluate the CARILLON device’s
ability to reduce mitral regurgitation, improve functional capacity and
quality of life as well as induce reverse ventricular remodeling in a
symptomatic heart failure patient population both at rest and during
exercise.
The REDUCE FMR clinical trial follows three successful multi-center
studies, featuring the CARILLON device – the AMADEUS,
TITAN and TITAN II trials. “My experiences with CARILLON have been
extremely positive. As an investigator in the last two multi-center
trials involving the CARILLON therapy I’ve seen significant clinical
improvement in patients who receive the device,” said Janusz Lipiecki,
M.D., of Clinique
Pôle Santé République in Clermont Ferrand, France. “In this latest
landmark trial, we expect to firmly establish the magnitude of benefit
that patients receive from CARILLON.”
“The outcomes from REDUCE FMR will be added to the positive data already
collected from nearly 100 treated patients evaluated during the three
previous prospective trials,” said Rick Stewart, Chief Executive Officer
of Cardiac Dimensions. “This is the first randomized, blinded study in
the field of FMR, making its results of critical importance in
understanding the clinical significance of the CARILLON device in this
underserved patient population.”
About CARILLON® Mitral Contour
System®
The CARILLON Mitral Contour System is a percutaneous mitral annuloplasty
treatment option that can be deployed rapidly and safely1,
utilizing standard interventional techniques. The implantable device
consists of a distal anchor and a proximal anchor connected by a shaping
ribbon and utilizes the heart’s venous anatomy to reshape the mitral
annulus. This approach allows for reduction of the dilated annulus,
addressing a root cause of functional mitral regurgitation (FMR).
CARILLON has demonstrated compelling efficacy, significantly improving
patients’ symptoms, mitral regurgitation and quality of life. In
addition, all adjunctive treatment options remain available after using
CARILLON, making it an ideal first-line therapy for FMR.
About Functional Mitral Regurgitation
An estimated 70 percent of the 26 million people worldwide with heart
failure suffer from functional mitral regurgitation (FMR). FMR typically
results from the dilation of the left ventricle, which is the main
pumping chamber in the heart. As the left ventricle increases in size,
the mitral valve also expands. This dimensional increase leads to mitral
regurgitation, which significantly reduces the amount of blood flow out
of the left ventricle and on to the body and its organs. FMR has been
associated with high rates of mortality, reduced functional capacity,
poor quality of life and an increase in patient hospitalizations.
Current mainstream therapies to address FMR are limited. A majority of
patients become refractory to medical therapy, which is the current
standard of care and traditional surgical intervention is associated
with high rates of operative morbidity and mortality.
About Cardiac Dimensions®
Cardiac Dimensions is a leader in the development of innovative,
minimally invasive treatment modalities to address heart failure and
related cardiovascular conditions. The company’s initial technology
platform, the CARILLON Mitral Contour System has been designed to
address functional mitral regurgitation, utilizing a novel percutaneous
approach. Cardiac Dimensions has operations in Kirkland, Washington;
Sydney, Australia and Offenbach, Germany. For more information, visit
the company’s web site: http://www.cardiacdimensions.com.
Cardiac Dimensions, CARILLON and Mitral Contour System are registered
trademarks of Cardiac Dimensions.
1 Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki
J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg S, Mehta N, Solomon
SD, Levy WC, Reuter DG. Treatment of functional mitral regurgitation by
percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail.
2012;14:931-38.
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